Intima-media thickness (IMT) provides a surrogate end point of cardiovascular outcomes in clinical trials evaluating the efficacy of cardiovascular risk factor modification. Carotid artery plaque ...further adds to the cardiovascular risk assessment. It is defined as a focal structure that encroaches into the arterial lumen of at least 0.5 mm or 50% of the surrounding IMT value or demonstrates a thickness >1.5 mm as measured from the media-adventitia interface to the intima-lumen interface. The scientific basis for use of IMT in clinical trials and practice includes ultrasound physics, technical and disease-related principles as well as best practice on the performance, interpretation and documentation of study results. Comparison of IMT results obtained from epidemiological and interventional studies around the world relies on harmonization on approaches to carotid image acquisition and analysis. This updated consensus document delineates further criteria to distinguish early atherosclerotic plaque formation from thickening of IMT. Standardized methods will foster homogenous data collection and analysis, improve the power of randomized clinical trials incorporating IMT and plaque measurements and facilitate the merging of large databases for meta-analyses. IMT results are applied to individual patients as an integrated assessment of cardiovascular risk factors. However, this document recommends against serial monitoring in individual patients.
Symptomatic intracranial atherothrombotic stenoses (ICAS) are associated with high rates of cerebrovascular ischemic events.
To conduct a prospective multicenter study to evaluate the natural history ...of ICAS and, in those patients refractory to medical treatment, the outcomes associated with intracranial angioplasty.
Patients aged 18 to 80 were enrolled with symptoms attributed to a single ICAS of > or =50%. Optimal medical therapy of vascular risk factors and preventive antithrombotic therapy were at the discretion of the local investigator. Patients were eligible for intracranial angioplasty after experiencing recurrent stroke despite medical therapy. Neurologic and ultrasonographic examinations were performed at study inclusion, 3 months after enrollment, and every 6 months of follow-up thereafter, for 36 months.
One hundred two patients were included, with a mean age of 63.3 +/- 10.4 years. Intracranial artery stenoses involved the vertebral artery in 22.5%, the basilar artery in 25.5%, the middle cerebral artery in 26.5%, and the internal carotid artery in 25.5%. In 27.4% of the patients, the stenoses had clinical hemodynamic characteristics. During a mean follow-up of 23.4 months, 38.2% of the patients had a cerebrovascular event: ischemic stroke in 13.7% and TIA in 24.5%. Among patients with a hemodynamically significant stenosis, 60.7% had a recurrent stroke or TIA in the territory of the stenotic artery; this association was significant in univariate analysis. Twenty-eight patients underwent an endovascular procedure with a neurologic periprocedural complication rate of 14.2%. The overall vascular death rate was 8.8%.
Despite medical treatment, the 2-year recurrence rate of ischemic events in the territory of the stenotic artery was 38.2%. Cardiovascular events occurred in 18.6% of patients. Clinically significant hemodynamic stenoses were associated with stroke recurrence and may help identify a high risk subset of patients.
This descriptive and analytical study investigated the consumption rates of psychoactive substances among individuals aged 18–25 years in France. More specifically, it enabled assessment of the ...extent of the neuroenhancement (NE) phenomenon among students in France (including study of the misuse of psychostimulant medicines).
COgnitive enhancement and consumption of psychoactive Substances among Youth Students (COSYS) is a cross-sectional survey of students in France.
Between January and June 2017, a questionnaire was mailed to students. All questionnaires were completed anonymously and included questions regarding the use of all kind of psychoactive substances, motivations for use and socio-economic situations. Statistics for all variables and the results of a multiple correspondence analysis (MCA) are presented.
This study recorded 46,203 respondents, mostly in universities (>60%), mostly women (63.4%), with an average age of 21.4 years. In terms of substance use, medications were cited in the third position after alcohol and tobacco by women (22.48%) and in the fourth position after alcohol, tobacco and cannabis by men (15.14%). Among medications, opiates were the most frequently used, followed by benzodiazepines. Students who declared a non-medical use (NMU) of drugs obtained these through various ways (e.g. family medicine cabinet, a friend, a dealer or via the Internet), or by increasing their recommended doses (e.g. codeine). In total, 18.6% of students consumed psychoactive substances for ‘stress management’ and 14.1% for ‘sleep management’. Results indicated that NE in students is a problem, with 18.6% of students in the COSYS survey confirming the use of psychoactive substances for this reason. There was a very low prevalence for psychostimulant medications (0.57% of men), mostly NMU (67%). MCA yielded three different profiles (doping candidate, experimenter and psychiatric profile) of psychostimulant users, which complicates the implementation of prevention programmes.
It is evident that NMU and ‘conventional’ use of medications are highly prevalent in French students, especially females. NMU is associated with substance use disorders, psychopathology and suicidality. Social norms and social media increase NMU of psychoactive substances, but also provide a potential platform for anti-NMU campaigns.
NCT02954679.
Objective To determine the efficacy and safety of enoxaparin compared with unfractionated heparin during percutaneous coronary intervention.Design Systematic review and meta-analysis.Data sources ...Medline and Cochrane database of systematic reviews, January 1996 to May 2011.Study selection Randomised and non-randomised studies comparing enoxaparin with unfractionated heparin during percutaneous coronary intervention and reporting on both mortality (efficacy end point) and major bleeding (safety end point) outcomes.Data extraction Sample size, characteristics, and outcomes, extracted independently and analysed.Data synthesis 23 trials representing 30 966 patients were identified, including 10 243 patients (33.1%) undergoing primary percutaneous coronary intervention for ST elevation myocardial infarction, 8750 (28.2%) undergoing secondary percutaneous coronary intervention after fibrinolysis, and 11 973 (38.7%) with non-ST elevation acute coronary syndrome or stable patients scheduled for percutaneous coronary intervention. A total of 13 943 patients (45.0%) received enoxaparin and 17 023 (55.0%) unfractionated heparin. Enoxaparin was associated with significant reductions in death (relative risk 0.66, 95% confidence interval 0.57 to 0.76; P<0.001), the composite of death or myocardial infarction (0.68, 0.57 to 0.81; P<0.001), and complications of myocardial infarction (0.75, 0.6 to 0.85; P<0.001), and a reduction in incidence of major bleeding (0.80, 0.68 to 0.95; P=0.009). In patients who underwent primary percutaneous coronary intervention, the reduction in death (0.52, 0.42 to 0.64; P<0.001) was particularly significant and associated with a reduction in major bleeding (0.72, 0.56 to 0.93; P=0.01).Conclusion Enoxaparin seems to be superior to unfractionated heparin in reducing mortality and bleeding outcomes during percutaneous coronary intervention and particularly in patients undergoing primary percutaneous coronary intervention for ST elevation myocardial infarction.
Few studies have directly compared the clinical features of neuropathic and non-neuropathic pains. For this purpose, the French Neuropathic Pain Group developed a clinician-administered questionnaire ...named DN4 consisting of both sensory descriptors and signs related to bedside sensory examination. This questionnaire was used in a prospective study of 160 patients presenting with pain associated with a definite neurological or somatic lesion. The most common aetiologies of nervous lesions (
n=89) were traumatic nerve injury, post herpetic neuralgia and post stroke pain. Non-neurological lesions (
n=71) were represented by osteoarthritis, inflammatory arthropathies and mechanical low back pain. Each patient was seen independently by two experts in order to confirm the diagnosis of neuropathic or non-neuropathic pain. The prevalence of pain descriptors and sensory dysfunctions were systematically compared in the two groups of patients. The analysis of the psychometric properties of the DN4 questionnaire included: face validity, inter-rater reliability, factor analysis and logistic regression to identify the discriminant properties of items or combinations of items for the diagnosis of neuropathic pain. We found that a relatively small number of items are sufficient to discriminate neuropathic pain. The 10-item questionnaire developed in the present study constitutes a new diagnostic instrument, which might be helpful both in clinical research and daily practice.
Previous data showed that non-invasive ventilation (NIV) applied for 3 min before tracheal intubation ensured better oxygenation compared with using a non-rebreather bag-valve-mask. We aimed to ...determine whether preoxygenation using NIV is effective in reducing the incidence of organ dysfunction in hypoxaemic, critically ill patients in intensive care.
A multicentre, randomised, open-label trial evaluating 100% FiO2 administered with NIV (99 patients) vs with face mask (102 patients) for 3 min before tracheal intubation. The primary endpoint was the maximal value of Sequential Organ Failure Assessment score within 7 days after intubation.
The median (inter-quartile range) values of the maximal value of the Sequential Organ Failure Assessment score within 7 days post-intubation were not significantly different between the two randomised groups: nine (6–12) in the NIV group vs 10 (6–12) in the face mask group (P=0.65). In patients treated by NIV prior to the randomisation, there was a significant increase in the occurrence in adverse events in patients randomised to face mask odds ratio=5.23 (1.61;16.99), P=0.0059.
This study failed to demonstrate any benefits of using NIV as a preoxygenation method to reduce organ dysfunction compared with usual preoxygenation in hypoxaemic, critically ill patients requiring tracheal intubation for invasive ventilation. NIV should not be discontinued for preoxygenation in the cases of patients treated by NIV before the decision to intubate.
NCT00472160.
Background
Multiple sclerosis (MS) is associated with regulatory T cells (Tregs) insufficiency while low-dose interleukin-2 (IL2
LD
) activates Tregs and reduces disease activity in autoimmune ...diseases.
Methods
We aimed at addressing whether IL2
LD
improved Tregs from MS patients. MS-IL2 was a single-center double-blind phase-2 study. Thirty patients (mean SD age 36.8 years 8.3, 16 female) with relapsing–remitting MS with new MRI lesions within 6 months before inclusion were randomly assigned in a 1:1 ratio to placebo or IL-2 at 1 million IU, daily for 5 days and then fortnightly for 6 months. The primary endpoint was change in Tregs at day-5.
Results
Unlike previous trials of IL2
LD
in more than 20 different autoimmune diseases, Tregs were not expanded at day-5 in IL2
LD
group, but only at day-15 (median IQR fold change from baseline: 1.26 1.21–1.33 in IL2
LD
group; 1.01 0.95–1.05 in placebo group, p < 0.001). At day-5, however, Tregs had acquired an activated phenotype (fold change of CD25 expression in Tregs: 2.17 1.70–3.55 in IL2
LD
versus 0.97 0.86–1.28 in placebo group, p < 0.0001). Regulator/effector T cells ratio remained elevated throughout treatment period in the IL2
LD
group (p < 0.001). Number of new active brain lesions and of relapses tended to be reduced in IL2
LD
treated patients, but the difference did not reach significance in this trial not powered to detect clinical efficacy.
Conclusion
The effect of IL2
LD
on Tregs in MS patients was modest and delayed, compared to other auto-immune diseases. This, together with findings that Tregs improve remyelination in MS models and recent reports of IL2
LD
efficacy in amyotrophic lateral sclerosis, warrants larger studies of IL2
LD
in MS, notably with increased dosages and/or modified modalities of administration.
Trial registration information
ClinicalTrials.gov: NCT02424396; EU Clinical trials Register: 2014-000088-42.
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